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Generated: April 19, 2019

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Details for New Drug Application (NDA): 017808

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NDA 017808 describes MIACALCIN, which is a drug marketed by Mylan Ireland Ltd and is included in two NDAs. It is available from two suppliers. Additional details are available on the MIACALCIN profile page.

The generic ingredient in MIACALCIN is calcitonin salmon. There are fourteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the calcitonin salmon profile page.
Summary for 017808
Applicant:Mylan Ireland Ltd
Ingredient:calcitonin salmon
Formulation / Manufacturing:see details
Pharmacology for NDA: 017808
Suppliers and Packaging for NDA: 017808
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIACALCIN calcitonin salmon INJECTABLE;INJECTION 017808 NDA Mylan Institutional LLC 67457-675 67457-675-02 1 VIAL, MULTI-DOSE in 1 CARTON (67457-675-02) > 2 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength100 IU/ML
Approval Date:Jul 3, 1986TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200 IU/ML
Approval Date:Mar 29, 1991TE:RLD:Yes

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